Recalls

All US Product Recalls

Searchable archive of product recalls from the FDA, USDA FSIS, CPSC, NHTSA, and EPA — translated into plain English, severity-scored from objective criteria, and always linked back to the original government notice.

Agency

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2251–2275 of 30649

HighFDA (Devices)·Z-1287-2026·2026-02-11
Disposable Sphincterotome Recall by Olympus for Potential Deformation and Performance Loss
Olympus is recalling 886 units of its Disposable Triple Lumen Sphincterotome (Model KD-401Q-0330) because some devices may not have undergone proper thermoforming and could deform and lose performance during use.
Product
Product Name: Disposable Triple Lumen Sphincterotome Model/Catalog Number: KD-401Q-0330 Product Description: These instruments have been designed to be used with an Olympus endoscope and guidewire for papillotomy using high-frequency current.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1304-2026·2026-02-11
Lumipulse pTau 217 Plasma Controls recalled for inaccurate test results
Fujirebio's Lumipulse pTau 217 Plasma Controls may produce inaccurate test results, causing false positive or indeterminate readings. This could lead to incorrect Alzheimer's disease diagnosis or unnecessary clinical testing.
Product
Product Name: Lumipulse pTau 217 Plasma Controls Model/Catalog Number: 81558 Software Version: Not Applicable Product Description: Lumipulse pTau 217 Plasma Controls: This quality control product can be used as an objective judgement of the laboratory s procedures and personn
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1311-2026·2026-02-11
Molift Sling Bars Recalled for Structural Defect in Patient Lift Devices
Molift 4-point sling bars are being recalled due to a bolt defect caused by material deformation between the lifting bar and device arm, which prevents proper device functionality.
Product
Brand Name: Molift Product Name: Molift 4-point sling bars (Accessory to mobile hoists) Model/Catalog Number: 1430116,1430117,1430115 Product Description: The mobile hoist is an assistive device intended for alleviation of, or compensation for, a functional, impairment due to
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1273-2026·2026-02-11
Olympus Sphincterotome V Devices Recalled for Potential Deformation
Olympus has recalled Single Use 3-Lumen Sphincterotome V devices (Model KD-V411M-0725) worldwide because some units may not have undergone proper thermoforming, which could cause deformation and performance loss.
Product
Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-V411M-0725; Software Version: N/A Product Description: These instruments have been designed to be used with an Olympus endoscope and guidewire for papillotomy using high-frequency current.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1226-2026·2026-02-11
OXIRIS Dialyzer Set Recalled Due to Potential Deaeration Chamber Dislodgement
VANTIVE US HEALTHCARE LLC is recalling 2,724 units of OXIRIS SET dialyzers nationwide due to potential dislodgement of the deaeration chamber, which could impair device function.
Product
OXIRIS SET, Product Code 112016; Dialyzer, High Permeability With Or Without Sealed Dialysate System
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1262-2026·2026-02-11
Male Fertility Sperm Test Distributed Without FDA Clearance Poses Inaccuracy Risk
Changchun Wancheng Bio-Electron's male fertility sperm test was distributed without required FDA clearance. The device may produce false diagnostic results when used at home.
Product
Male Fertility Sperm Test for Home Use (Cassette)
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1236-2026·2026-02-11
VITEK 2 Gram-negative Susceptibility Cards Risk of False Antibiotic Resistance Results
Biomerieux is recalling VITEK 2 Gram-negative Susceptibility Cards due to potential quality control failures and false antibiotic resistance results. The cards are used in clinical laboratories for antibiotic susceptibility testing.
Product
VITEK 2 Gram-negative Susceptibility Cards Containing o Polymyxin B (pb02n) o Ceftazidime/avibactam (cza02n) o Meropenem/Vaborbactam (mev01n) o Imipenem (ipm05n) o Imipenem/Relebactam (ipr01n); CARD NAME/ PRODUCT REFERENCE: AST-N399 423701 AST-N402 423644 AST-N403 42364
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1266-2026·2026-02-11
FDA recalls Vivoo Vaginal pH Test for inaccurate diagnostic results
The FDA is recalling Vivoo Vaginal pH Test kits distributed without FDA clearance. The tests may produce false or inaccurate results, potentially leading to inappropriate medical decisions.
Product
Vivoo Vaginal pH Test
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1263-2026·2026-02-11
Exploro Male Fertility Test Recalled for Inaccurate Diagnostic Results
Changchun Wancheng Bio-Electron's Exploro male fertility test was distributed without required FDA clearance and may produce false or inaccurate results, potentially leading to inappropriate medical decisions.
Product
Exploro Highly Sensitive Male Fertility / Sperm Concentration Test
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1289-2026·2026-02-11
Olympus Disposable Sphincterotome Recalled for Potential Performance Loss
Olympus recalls 1,490 Disposable Triple Lumen Sphincterotomes due to a manufacturing defect where improper thermoforming could cause the devices to deform and lose performance during surgical use.
Product
Product Name: Disposable Triple Lumen Sphincterotome Model/Catalog Number: KD-401Q-0730 Product Description: These instruments have been designed to be used with an Olympus endoscope and guidewire for papillotomy using high-frequency current.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1303-2026·2026-02-11
Lumipulse G pTau 217 Plasma Calibrators recalled for inaccurate results
Fujirebio Diagnostics is recalling Lumipulse G pTau 217 Plasma Calibrators due to inaccurate test results that could incorrectly classify patients as having or not having Alzheimer's amyloid pathology.
Product
Product Name: Lumipulse G pTau 217 Plasma Calibrators Model/Catalog Number: 81557 Software Version: Not Applicable Product Description: Lumipulse G pTau 217 Plasma Calibrators: The pTau 217 plasma concentration of a specimen is automatically calculated from the calibration cu
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1288-2026·2026-02-11
Olympus Disposable Triple Lumen Sphincterotome devices recalled for deformation risk
Olympus recalls Disposable Triple Lumen Sphincterotome Model KD-401Q-0720 devices due to manufacturing defects that could cause device deformation and loss of performance during medical procedures.
Product
Product Name: Disposable Triple Lumen Sphincterotome Model/Catalog Number: KD-401Q-0720 Product Description: These instruments have been designed to be used with an Olympus endoscope and guidewire for papillotomy using high-frequency current.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1286-2026·2026-02-11
Olympus Disposable Triple Lumen Sphincterotome Recall Due to Manufacturing Defect
Olympus is recalling 887 units of the Disposable Triple Lumen Sphincterotome due to a manufacturing defect. Devices that did not undergo thermoforming could deform and lose performance during use.
Product
Product Name: Disposable Triple Lumen Sphincterotome Model/Catalog Number: KD-411Q-0730 Product Description: These instruments have been designed to be used with an Olympus endoscope and guidewire for papillotomy using high-frequency current.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1278-2026·2026-02-11
Olympus Sphincterotome V Recalled Due to Potential Device Deformation
Olympus recalls single-use sphincterotomes that may deform and lose performance if not properly thermoformed during manufacturing. No injuries have been reported.
Product
Product Name: Single Use 3-Lumen Sphincterotome V (Distal Wire guided) Model/Catalog Number: KD-VC411Q-0720; Software Version: N/A Product Description: These instruments have been designed to be used with an Olympus endoscope and guidewire for papillotomy using high-frequency
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1277-2026·2026-02-11
Olympus Sphincterotome V devices recalled due to performance loss
Olympus is recalling 4,183 Single Use 3-Lumen Sphincterotome V devices because some units did not undergo thermoforming, which could cause deformation and loss of performance.
Product
Product Name: Single Use 3-Lumen Sphincterotome V (Distal Wire guided) Model/Catalog Number: KD-VC431Q-0730; Software Version: N/A Product Description: These instruments have been designed to be used with an Olympus endoscope and guidewire for papillotomy using high-frequency
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1285-2026·2026-02-11
FDA Recalls Disposable Triple Lumen Sphincterotome Due to Thermoforming Defect
Olympus recalls approximately 125 units of the Disposable Triple Lumen Sphincterotome (Model KD-411Q-0720) worldwide due to thermoforming defects that could cause device deformation and loss of performance.
Product
Product Name: Disposable Triple Lumen Sphincterotome Model/Catalog Number: KD-411Q-0720 Product Description: These instruments have been designed to be used with an Olympus endoscope and guidewire for papillotomy using high-frequency current.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1252-2026·2026-02-11
Vortex Surgical I2 Injection Kit Recall: Potential Seal Defects
Vortex Surgical is recalling its I2 Injection Kits (model VS0500) due to potential voids in pouch seals that could compromise the sterile barrier and cause infection. Affected are 14,789 units distributed nationwide and internationally.
Product
Vortex Surgical I2 Injection Kit, VS0500
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1284-2026·2026-02-11
Olympus Single-Use Sphincterotome V Recalled for Manufacturing Thermoforming Defect
Olympus Corporation recalls 93 Single-Use 3-Lumen Sphincterotome V devices due to improper thermoforming that may cause deformation and performance loss. Affected devices were distributed nationwide and internationally.
Product
Product Name: Single Use 3-Lumen Sphincterotome V (Distal Wire guided) Model/Catalog Number:KD-VC433Q-0730; Software Version: N/A Product Description: These instruments have been designed to be used with an Olympus endoscope and guidewire for papillotomy using high-frequency c
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1231-2026·2026-02-11
PRISMAFLEX TPE2000 dialyzer sets recalled for chamber dislodgement
VANTIVE US HEALTHCARE is recalling 13,760 PRISMAFLEX TPE2000 dialyzer sets nationwide due to potential dislodgement of the deaeration chamber from the control unit.
Product
PRISMAFLEX TPE2000 SET, Product Code 114093; Dialyzer, High Permeability With Or Without Sealed Dialysate System
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1279-2026·2026-02-11
Olympus Sphincterotome V Surgical Instrument Recalled for Deformation Risk
Olympus Corporation is recalling 10,257 units of Single Use 3-Lumen Sphincterotome V endoscopic instruments. Some devices did not undergo thermoforming during manufacturing and could deform and lose performance.
Product
Product Name: Single Use 3-Lumen Sphincterotome V (Distal Wire guided) Model/Catalog Number: KD-VC411Q-0730; Software Version: N/A Product Description: These instruments have been designed to be used with an Olympus endoscope and guidewire for papillotomy using high-frequency
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1274-2026·2026-02-11
Olympus Single Use 3-Lumen Sphincterotome V Recalled Due to Deformation Risk
Olympus Corporation is recalling the Single Use 3-Lumen Sphincterotome V surgical device due to a manufacturing defect where some devices may not have undergone proper thermoforming, potentially causing deformation and performance loss during surgical procedures.
Product
Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-V411M-0730; Software Version: N/A Product Description: These instruments have been designed to be used with an Olympus endoscope and guidewire for papillotomy using high-frequency current.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1229-2026·2026-02-11
Prismaflex HF1000 Dialyzer Set Recalled for Potential Chamber Dislodgement
Vantive US Healthcare is recalling the Prismaflex HF1000 SET dialyzer due to a potential dislodgement of the deaeration chamber from the control unit. The recall affects 93,576 units distributed nationwide.
Product
PRISMAFLEX HF1000 SET, Product Code 107140; Dialyzer, High Permeability With Or Without Sealed Dialysate System
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1233-2026·2026-02-11
EMPOWR 3D Knee Tibial Insert Packaging Error May Deliver Wrong Device
Encore Medical recalled EMPOWR 3D Knee Tibial Insert devices and other orthopedic implants due to packaging discrepancies that may deliver wrong devices, potentially requiring surgical delay or revision procedures.
Product
EMPOWR 3D Knee Tibial Insert 5R 14MM, VE, REF: 342-14-705
Category
Medical Device
Distribution
14 states
HighFDA (Devices)·Z-1257-2026·2026-02-11
UTI Test Strips Recalled for False or Inaccurate Diagnostic Results
Multiple brands of UTI test strips have been recalled for distribution before FDA clearance. The strips may produce false or inaccurate results that could lead to inappropriate medical decisions.
Product
LotFancy Urinary Tract Infection Urine (UTI) Test Strips; PALINOIA UTI-10 PARAMETER REAGENT STRIPS; Vaunn Medical 8-in-1 Urinalysis Reagent Strip; JNW Direct 4-in-1 UTl Urinalysis Test Strips; Urinify STRENGTH; Urinify ESSENTIAL, Urinify Urinary Tract Infection (UTI)
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1239-2026·2026-02-11
Siemens SOMATOM X.ceed CT system software applications recalled for lacking FDA clearance
Siemens is removing three software applications from SOMATOM X.ceed CT systems worldwide because they lack FDA 510(k) clearance. Affected units are being recalled to ensure regulatory compliance.
Product
SOMATOM X.ceed Software applications: syngo.CT Brain Quantification syngo.CT Vessel Hyperdensities syngo.CT ASPECTS
Category
Medical Device
Distribution
Distributed nationwide

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